FDA Adverse Event
Injury
Summary report: N
ADAPTA DR
MDR report key: 3861530
·
Received June 10, 2014
Report
- Report Number
- 3004209178-2014-11188
- Event Type
- Injury
- Date Received
- June 10, 2014
- Report Date
- April 14, 2014
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- NVZ
- PMA / PMN Number
- P980035
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCTS: 556845 LEAD, (B)(6) 2005. A 407458 LEADS, (B)(6) 2007. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAD CHRONIC INFECTION SYMPTOMS AND THE IMPLANTABLE PULSE GENERATOR (IPG) NEARLY ERODED THROUGH THE LEFT SUBCLAVIAN POCKET SITE. IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD HIGH PACING THRESHOLDS. THE ENTIRE PACING SYSTEM WAS EXPLANTED AND REPLACED ON THE RIGHT SIDE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 343087 | ADAPTA DR | PULSE GENERATOR, PERMANENT, IMPLANTABLE | NVZ | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | ADDR01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00090 YR | Hospitalization| R | 407458 LEAD |